Hydrus Microstent

FDA Premarket Approval P170034 S004

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval of the revised protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p170034

DeviceHydrus Microstent
Generic NameIntraocular Pressure Lowering Implant
ApplicantIvantis, Inc.
Date Received2019-11-27
Decision Date2020-01-23
PMAP170034
SupplementS004
Product CodeOGO 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product No
Applicant Address Ivantis, Inc. 38 Discovery, Suite 150 irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P170034Original Filing
S004 2019-11-27 Normal 180 Day Track No User Fee
S003 2019-08-27 Normal 180 Day Track No User Fee
S002 2019-07-24 Normal 180 Day Track No User Fee
S001 2018-09-07 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
20867487000138 P170034 000

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